U.S. patent application number 12/128419 was filed with the patent office on 2009-12-03 for self-sealing assembly for preventing fluid leakage from medical device.
This patent application is currently assigned to OBP Corporation. Invention is credited to Tracy Ann Jay-Robinson.
Application Number | 20090299336 12/128419 |
Document ID | / |
Family ID | 41377550 |
Filed Date | 2009-12-03 |
United States Patent
Application |
20090299336 |
Kind Code |
A1 |
Jay-Robinson; Tracy Ann |
December 3, 2009 |
Self-Sealing Assembly for Preventing Fluid Leakage from Medical
Device
Abstract
Self-sealing assemblies and methods of establishing a fluid-seal
around a medical instrument are disclosed herein. An assembly for
providing resistance to fluid leakage includes an introducer
section having a mouth portion, a stem portion, and a longitudinal
axis therebetween, wherein a diameter of the mouth portion
decreases over a length of the mouth portion, and wherein a
diameter of the stem portion remains substantially the same over a
length of the stem portion; a transfer section having a proximal
end and a distal end; and a self-sealing membrane at a junction
between the stem portion and the proximal end of the transfer
section, wherein the self-sealing membrane is composed of a single
piece flexible elastomeric material, and wherein the diameter and
the length of the stem portion and a thickness and a diameter of
the self-sealing membrane provide structural integrity to the
assembly resulting in the ability of the self-sealing membrane to
resist fluid leakage prior to, during, and after the self-sealing
membrane is punctured.
Inventors: |
Jay-Robinson; Tracy Ann;
(Jamaica Plain, MA) |
Correspondence
Address: |
GREENBERG TRAURIG, LLP
ONE INTERNATIONAL PLACE, 20th FL, ATTN: PATENT ADMINISTRATOR
BOSTON
MA
02110
US
|
Assignee: |
OBP Corporation
|
Family ID: |
41377550 |
Appl. No.: |
12/128419 |
Filed: |
May 28, 2008 |
Current U.S.
Class: |
604/533 |
Current CPC
Class: |
A61B 1/018 20130101;
A61B 1/00137 20130101 |
Class at
Publication: |
604/533 |
International
Class: |
A61M 5/00 20060101
A61M005/00 |
Claims
1. An assembly for providing resistance to fluid leakage
comprising: an introducer section having a mouth portion, a stem
portion, and a longitudinal axis therebetween, wherein a diameter
of the mouth portion decreases over a length of the mouth portion,
and wherein a diameter of the stem portion remains substantially
the same over a length of the stem portion; a transfer section
having a proximal end and a distal end; and a self-sealing membrane
at a junction between the stem portion and the proximal end of the
transfer section, wherein the self-sealing membrane is composed of
a single piece flexible elastomeric material, and wherein the
diameter and the length of the stem portion and a thickness and a
diameter of the self-sealing membrane provide structural integrity
to the assembly resulting in the ability of the self-sealing
membrane to resist fluid leakage prior to, during, and after the
self-sealing membrane is punctured.
2. The assembly of claim 1 wherein the introducer section is
approximately funnel-shaped.
3. The assembly of claim 1 wherein the introducer section, the
transfer section and the self-sealing membrane are fabricated using
a single piece of elastomeric material.
4. The assembly of claim 3 wherein the elastomeric material is a
translucent silicone elastomer.
5. The assembly of claim 1 wherein the length of the stem portion
is in a range of about 3 mm to about 4 mm.
6. The assembly of claim 1 wherein the diameter of the stem portion
is in a range of about 0.6 mm to about 3 mm.
7. The assembly of claim 1 wherein the thickness of the
self-sealing membrane is in a range of about 0.3 mm to about 2
mm.
8. The assembly of claim 1 wherein the transfer section is capable
of engaging to at least one of a Luer-lock adaptor, a
ball-in-socket adaptor, or a Tuohy Borst adaptor.
9. The assembly of claim 1 wherein the self-sealing membrane is
punctured using an auxiliary instrument.
10. The assembly of claim 9 wherein a hole is created in the
self-sealing membrane by the auxiliary instrument.
11. The assembly of claim 10 wherein the hole created in the
self-sealing membrane results in the auxiliary instrument passing
through the self-sealing membrane and into the transfer
section.
12. The assembly of claim 11 wherein the self-sealing membrane
surrounds the auxiliary instrument as the instrument passes through
the self-sealing membrane resulting in a fluid-seal around the
auxiliary instrument.
13. The assembly of claim 12 wherein the self-sealing membrane
extends from the stem portion such that any lateral movement
imparted by the auxiliary instrument to the stem portion is
transferred to the self-sealing membrane, resulting in the
self-sealing membrane remaining centered on the auxiliary
instrument and providing the fluid-seal.
14. The assembly of claim 12 wherein when the auxiliary instrument
is passed back through the self-sealing membrane and into the
introducer section, the hole created in the self-sealing membrane
relaxes so that the perforation is substantially closed resulting
in a seal.
15. The assembly of claim 12 wherein a ratio of the thickness of
the self-sealing membrane to the diameter of the self sealing
membrane is chosen such that when the auxiliary instrument is
passed back through the self-sealing membrane and into the
introducer section the self sealing membrane remains substantially
closed even if fluid or gas pressure is present in the
assembly.
16. An assembly for providing resistance to fluid backflow
comprising: an outer circumferential surface having a proximal end,
a distal end, and a middle region therebetween, wherein the middle
region includes a proximal lip, a distal lip, and a cavity
therebetween; and an inner body having an introducer section, a
transfer section, and a self-sealing membrane therebetween, wherein
the introducer section is approximately funnel-shaped, having a
first portion, a second portion, and a longitudinal axis
therebetween, wherein a diameter of the first portion decreases
over a first length, and wherein a diameter of the second portion
remains substantially the same over a second length, wherein the
transfer section has a proximal end, a distal end, and a
longitudinal axis therebetween, and wherein the self-sealing
membrane is composed of a single piece flexible elastomeric
material having a thickness such that the self-sealing membrane
extends from the second portion of the introducer section into the
transfer section when pressure is applied to the self-sealing
membrane.
17. The assembly of claim 16 wherein an elastic rubber band engages
the cavity of the middle region.
18. The assembly of claim 17 wherein the elastic rubber band
indicates the diameter of the second portion of the introducer
section.
19. The assembly of claim 16 wherein the pressure applied to the
self-sealing membrane causes the self-sealing membrane to stretch
in a direction from the proximal end of the transfer section
towards the distal end of the transfer section, wherein the
self-sealing membrane surrounds at least a portion of the medical
instrument as the self-sealing membrane is stretched, wherein a
hole having a diameter is created in the self-sealing membrane
resulting in the medical instrument passing through the
self-sealing membrane and into the transfer section, wherein the
self-sealing membrane surrounds the medical instrument as the
medical instrument passes through the self-sealing membrane
resulting in a fluid-seal around the medical instrument, and
wherein the diameter and the length of the second portion and the
thickness of the self-sealing membrane provide structural integrity
to the assembly resulting in the ability of the self-sealing
membrane to resist fluid backflow after the medical instrument is
removed from the assembly.
20. A method for establishing a fluid-seal around a medical
instrument comprising: attaching an assembly to an accessory
channel of a medical device, wherein the assembly comprises an
introducer section, a transfer section, and a self-sealing membrane
therebetween, wherein the introducer section is approximately
funnel-shaped, having a first portion, a second portion, and a
longitudinal axis therebetween, wherein a diameter of the first
portion decreases over a first length, and wherein a diameter of
the second portion remains substantially the same over a second
length, wherein the self-sealing membrane is composed of a single
piece flexible elastomeric material, and wherein the transfer
section is attached to the accessory channel of the medical device;
introducing the medical instrument into the introducer section of
the assembly such that the first portion guides the medical
instrument into the second portion, and the second portion contacts
and squeezes the medical instrument as the medical instrument
passes through the length of the second portion; exerting pressure
on the self-sealing membrane by the medical instrument resulting in
the self-sealing membrane stretching in a direction from a proximal
end of the transfer section towards a distal end of the transfer
section; and creating a hole in the self-sealing membrane such that
the medical instrument engages an entire inner surface of the hole
as the medical instrument passes through the self-sealing membrane
and into the transfer section, resulting in the fluid-seal around
the medical instrument.
Description
RELATED APPLICATIONS
[0001] None.
FIELD
[0002] The embodiments disclosed herein relate to self-sealing
assemblies for medical devices, and more particularly to
self-sealing assemblies to prevent fluid leakage and backflow and
methods of using self-sealing assemblies during a medical
procedure.
BACKGROUND
[0003] Endoscopes are medical viewing instruments with capabilities
of diagnostic (biopsy) or even therapeutic functions through
special operative channels. Endoscopes now have widespread use in
medicine and guide a myriad of diagnostic and therapeutic
procedures including, but not limited to, arthroscopy,
bronchoscopy, colonoscopy, colposcopy, cystoscopy, gastroscopy,
hysteroscopy, laparoscopy, laryngoscopy, proctoscopy and
thoracoscopy. For example, hysteroscopy is the inspection of the
uterine cavity by endoscopy and allows for the diagnosis of
intrauterine pathology and serves as a method for surgical
intervention. Hysteroscopes are endoscopes that are used during
hysteroscopy and are typically provided with at least one accessory
channel which permits the introduction of various surgical
auxiliary instruments, such as forceps, scissors or other
specialized biopsy instruments. Such auxiliary instruments are
introduced into the accessory channel through an inlet port. The
inlet port is therefore a site of potential escape of blood and
other bodily fluids (biomaterials), as well as introduced fluids,
which may result in the leaking or spraying of medical personnel
and equipment. These fluids may contain viruses and other
biological agents that pose a risk to the personnel or that
contaminate the equipment.
[0004] Because of the potential for the leakage of fluids, various
types of valves, plugs and seals are typically placed at or near
the inlet port. These plugs attempt to seal the tiny spaces around
the auxiliary instrument where the potential for leakage is
greatest, and are used to close off the inlet port when an
auxiliary instrument is not in place. However, the current surgical
plugs still have a tendency to leak, especially if multiple
auxiliary instruments are used. Additionally, current surgical
plugs can only be used with auxiliary instruments having a
relatively narrow range of diameters. Current large diameter
surgical valves do not close completely and require that the
auxiliary instrument be left in place to maintain a seal. Current
surgical valves require constant manipulation to maintain a seal
around the auxiliary instrument without excessive friction. Between
the time an auxiliary instrument is removed from the endoscope and
the accessory-port valve is closed, blood or other bodily fluid can
leak or spray from the port because the seal does not effectively
self-close. This happens because the seal around the auxiliary
instrument may be distorted by an instrument that previously passed
through and stretched the aperture. These problems and shortcomings
may be solved by the self-sealing assemblies of the present
disclosure
SUMMARY
[0005] Self-sealing assemblies for the prevention of fluid leakage
from a medical device and methods of using these assemblies during
a medical procedure are disclosed herein. According to aspects
illustrated herein, there is provided an assembly for providing
resistance to fluid leakage that includes an introducer section
having a mouth portion, a stem portion, and a longitudinal axis
therebetween, wherein a diameter of the mouth portion decreases
over a length of the mouth portion, and wherein a diameter of the
stem portion remains substantially the same over a length of the
stem portion; a transfer section having a proximal end and a distal
end; and a self-sealing membrane at a junction between the stem
portion and the proximal end of the transfer section, wherein the
self-sealing membrane is composed of a single piece flexible
elastomeric material, and wherein the diameter and the length of
the stem portion and a thickness and a diameter of the self-sealing
membrane provide structural integrity to the assembly resulting in
the ability of the self-sealing membrane to resist fluid leakage
prior to, during, and after the self-sealing membrane is
punctured.
[0006] According to aspects illustrated herein, there is provided
an assembly for providing resistance to fluid backflow that
includes an outer circumferential surface having a proximal end, a
distal end, and a middle region therebetween, wherein the middle
region includes a proximal lip, a distal lip, and a cavity
therebetween; and an inner surface having an introducer section, a
transfer section, and a self-sealing membrane therebetween, wherein
the introducer section is approximately funnel-shaped, having a
first portion, a second portion, and a longitudinal axis
therebetween, wherein a diameter of the first portion decreases
over a first length, and wherein a diameter of the second portion
remains substantially the same over a second length, wherein the
transfer section has a proximal end, a distal end, and a
longitudinal axis therebetween, and wherein the self-sealing
membrane is composed of a single piece flexible elastomeric
material having a thickness such that the self-sealing membrane
extends from the second portion of the introducer section into the
transfer section when pressure is applied to the self-sealing
membrane.
[0007] According to aspects illustrated herein, there is provided a
method for establishing a fluid-seal around a medical instrument
that includes attaching an assembly to an accessory channel of a
medical device, wherein the assembly comprises an introducer
section, a transfer section, and a self-sealing membrane
therebetween, wherein the introducer section is approximately
funnel-shaped, having a first portion, a second portion, and a
longitudinal axis therebetween, wherein a diameter of the first
portion decreases over a first length, and wherein a diameter of
the second portion remains substantially the same over a second
length, wherein the self-sealing membrane is composed of a single
piece flexible elastomeric material, and wherein the transfer
section is attached to the accessory channel of the medical device;
introducing the medical instrument into the introducer section of
the assembly such that the first portion guides the medical
instrument into the second portion, and the second portion contacts
and squeezes the medical instrument as the medical instrument
passes through the length of the second portion; exerting pressure
on the self-sealing membrane by the medical instrument resulting in
the self-sealing membrane stretching in a direction from a proximal
end of the transfer section towards a distal end of the transfer
section; and creating a hole in the self-sealing membrane such that
the medical instrument engages an entire inner surface of the hole
as the medical instrument passes through the self-sealing membrane
and into the transfer section, resulting in the fluid-seal around
the medical instrument.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The presently disclosed embodiments will be further
explained with reference to the attached drawings, wherein like
structures are referred to by like numerals throughout the several
views. The drawings shown are not necessarily to scale, with
emphasis instead generally being placed upon illustrating the
principles of the presently disclosed embodiments.
[0009] FIGS. 1A, 1B and 1C show an embodiment of a self-sealing
assembly of the present disclosure. FIG. 1A shows a perspective
view of the self-sealing assembly. FIG. 1B shows a perspective
cross-sectional view of the self-sealing assembly. FIG. 1C shows a
cross-sectional view of the self-sealing assembly.
[0010] FIGS. 2A and 2B show an embodiment of a self-sealing
assembly of the present disclosure. FIG. 2A shows a top view of the
self-sealing assembly. FIG. 2B shows a bottom view of the
self-sealing assembly.
[0011] FIGS. 3A, 3B and 3C show an embodiment of a self-sealing
assembly of the present disclosure being engaged to a Luer-lock
adaptor. FIG. 3A shows a side view of the Luer-lock adaptor and the
self-sealing assembly prior to engagement. FIG. 3B shows a side
view of the Luer-lock adaptor and the self-sealing assembly during
engagement. FIG. 3C shows a side view of the Luer-lock adaptor and
the self-sealing assembly after engagement.
[0012] FIGS. 4A and 4B show an embodiment of the self-sealing
assembly of FIG. 3C being engaged to a Luer-lock fitted accessory
channel on a hysteroscope. FIG. 4A shows a side view of the
self-sealing assembly prior to engagement to the hysteroscope. FIG.
4B shows a side view of the self-sealing assembly after engagement
to the hysteroscope.
[0013] FIGS. 5A, 5B and 5C show an embodiment of a self-sealing
assembly of the present disclosure being engaged to a Luer-lock
fitted accessory channel on a hysteroscope. FIG. 5A shows a side
view of the self-sealing assembly prior to engagement to the
hysteroscope. FIG. 5B shows a side view of the self-sealing
assembly during engagement to the hysteroscope. FIG. 5C shows a
side view of the self-sealing assembly after engagement to the
hysteroscope.
DETAILED DESCRIPTION
[0014] Self-sealing assemblies that are capable of preventing fluid
leakage and backflow are disclosed herein. Methods of using these
self-sealing assemblies in conjunction with medical instruments
during a medical procedure are also disclosed. In an embodiment,
the self-sealing assemblies of the present disclosure are provided
for single-use and are disposable. The self-sealing assemblies are
designed to be placed directly over an inlet port of an accessory
channel of a medical device or alternatively, may be engaged to an
adaptor which is attached to the inlet port of the accessory
channel. For example, the self-sealing assemblies may be engaged
with a Luer-lock adaptor, a ball-in-socket adaptor, or a Tuohy
Borst adaptor.
[0015] As used herein, the term "endoscope" generally refers to a
medical device having a light attached that is used to look inside
a body cavity or organ. The self-sealing assemblies of the present
disclosure may be used with various types of endoscopes including,
but not limited to, hysteroscopes and resectoscopes. In an
embodiment, the self-sealing assemblies of the present disclosure
are used in conjunction with a hysteroscope during an operative
hysteroscopy procedure. It should be understood that the
self-sealing assemblies of the present disclosure can be used with
any type of medical device for which a fluid-seal is desired, such
as various scopes and catheters.
[0016] As used herein, the term "hysteroscope" refers to a thin
telescope for minimally invasive operative access to the interior
of a subject's uterus. A typical hysteroscope used during an
operative hysteroscopy procedure includes at least one "accessory
channel" or "operative channel", which is a lumen for the insertion
of auxiliary instruments or distention media. To accomplish
insufflation (distention) of a subject's uterus, a gas feed line
may be attached to a gas port on the hysteroscope which feeds into
the operative channel. By using a hysteroscope having one operative
channel for gas insufflation and for auxiliary instrument (e.g.,
forceps) insertion, the insertion arm of the hysteroscope may be
minimized, permitting comfortable and easy uterine access as well
as access without inducing dilation.
[0017] As used herein, the term "self-sealing" refers to a feature
of any one of the assemblies of the presently disclosed
embodiments. The presently disclosed assemblies include a flexible
elastomeric membrane having a thickness to a diameter ratio such
that the membrane is capable of sealing itself after being
punctured.
[0018] As used herein, the term "resistance to fluid leakage"
refers to a feature of any one of the self-sealing assemblies of
the presently disclosed embodiments where the leakage of fluid from
a medical device is minimized.
[0019] As used herein, the term "backflow" refers to the reversal
of fluid or biomaterial flow from a medical device. Backflow is
generally undesirable in medical procedures.
[0020] As used herein, the term "auxiliary instrument" refers to an
instrument that may be inserted into any one of the self-sealing
assemblies of the presently disclosed embodiments any manipulated
during a medical procedure. Examples of auxiliary instruments
include, but are not limited to, catheters, guide wires, forceps,
scissors, cystoscopic graspers, hysteroscopic graspers, monopolar
and bipolar electrodes, ureteral stints, morcellation devices,
electrosurgical probes, stone baskets and retrievers.
[0021] As used herein, the term "approximately funnel-shaped"
denotes a three-dimensional cylinder that has a diameter at one end
larger than the other, i.e., in the shape of a cone.
[0022] As used herein, the term "elastomeric material" refers to a
polymer with the property of elasticity. Silicone elastomer is a
polymer that has a "backbone" of silicone-oxygen linkages.
"Silastic" refers to the trademark name registered by Dow Corning
Corporation for polymeric silicone elastomeric substances that have
the properties of rubber but are biologically inert. In an
embodiment, the medical assemblies of the present disclosure are
fabricated from Silastic.RTM.. In an embodiment, the Silastic.RTM.
is a GP 500 silicone rubber manufactured from Dow Corning
Corporation.
[0023] As used herein, the term "hugging" refers to a feature
provided by any one of the self-sealing assemblies of the presently
disclosed embodiments. The presently disclosed self-sealing
assemblies include an introducer section having a narrow stem
portion that is capable of completely contacting, surrounding, and
gently squeezing an auxiliary instrument as it passes through the
stem portion. Such hugging prevents fluid, even under pressure,
from extruding around the auxiliary instrument as it passes through
the stem portion of the self-sealing assembly.
[0024] As used herein, the term "structural integrity" refers to a
feature provided by an assembly of the presently disclosed
embodiments prior to, during, and after puncture by a medical
instrument, as well as after the medical instrument is removed from
the assembly. When an assembly of the presently disclosed
embodiments is placed on a hysteroscope for use during a medical
procedure, prior to being punctured by an auxiliary medical
instrument, the self-sealing membrane of the assembly provides
resistance to fluid backflow out of the assembly. The self-sealing
membrane is fabricated from a single-piece material that blocks
fluid from passing through the self-sealing membrane. After being
punctured by the auxiliary instrument, the structural design of the
internal portions of the assembly provides the ability to resist
fluid backflow. The assembly hugs the auxiliary instrument and
surrounds and supports the auxiliary instrument. During use, the
structural design of the internal portions of the assembly provides
the ability to resist fluid backflow. The self-sealing membrane
mimics any lateral movement imparted on the small diameter internal
portions leading up to the self-sealing membrane by the auxiliary
instrument, and thus any lateral movement will be transferred to
the self-sealing membrane such that a center of the self-sealing
membrane is always aligned with a center of the auxiliary
instrument. This "floating membrane" design insures leakage is
prevented during any lateral movement by the auxiliary instrument.
A ratio of the thickness of the self-sealing membrane to the
diameter of the self sealing membrane is chosen such that the self
sealing membrane provides resistance to fluid leakage even after
the auxiliary instrument is removed from the self-sealing membrane.
The self-sealing membrane will remain substantially closed even if
fluid or gas pressure is present in the assembly.
[0025] As shown in the perspective view of FIG. 1A, a self-sealing
assembly 10 of the present disclosure has a tubular shape and
includes a proximal end 12, a distal end 14 and a middle region 17
therebetween. In an embodiment, a longitudinal length of the
assembly 10 is from about 15 mm to about 18 mm. The proximal end 12
of the assembly 10 is that end into which an auxiliary instrument
would be inserted, while the distal end 14 of the assembly 10 is
that end that would be placed over an inlet port to an accessory
channel on a medical device. The assembly 10 may be attached
directly to the inlet port, or alternatively, may be engaged with
an adaptor that is attached to a fitting on the inlet port, as will
be described in more detail below. Middle region 17 has a proximal
lip 18a, a distal lip 18b, and a cavity 19 therebetween. The middle
region 17 extends outward beyond an outer circumferential surface
16 of the assembly 10. In an embodiment, an elastic band is wrapped
around the assembly 10 such that it is housed within the cavity 19.
The elastic band may be fabricated from different colors which
represent a diameter of an internal feature of the assembly 10, as
will be described in more detail below.
[0026] FIG. 1B shows a perspective cross-sectional view of the
assembly 10. The assembly 10 includes a body 21 having two
longitudinally adjacent sections, an introducer section 20 and a
transfer section 30, separated from one another by a flexible
membrane 28. The introducer section 20 has a proximal section 24, a
distal section 26, and a longitudinal axis therebetween. In an
embodiment, the distal section 26 is aligned centrally with respect
to the proximal section 24. In an embodiment, the introducer
section 20 is approximately funnel-shaped, having a wide conical
shaped mouth as the proximal section 24 for receiving an auxiliary
instrument, and a narrow stem shaped distal section 26 for
contacting and squeezing the auxiliary instrument as the instrument
passes through the distal section 26. The conical shaped mouth
portion 24 has a diameter that gradually decreases over a length of
the mouth portion 24, such that a first or initial diameter at a
proximal end of the mouth portion 24 is larger than a second or
final diameter at a distal end of the mouth portion 24. The
funnel-shape of the introducer section 20 is designed in such a way
that the auxiliary instrument may be placed within the assembly 10
with ease, and the auxiliary instrument may be guided and squeezed
towards the membrane 28. The stem portion 26 is designed to have a
desired length and a desired diameter such that the auxiliary
instrument is squeezed as the instrument is directed through the
length of the stem portion 26 towards the membrane 28. In an
embodiment, a diameter of the stem portion 26 is constant along the
entire length of the stem portion 26. In an embodiment, the
diameter of the stem portion 26 gradually decreases along the
length of the stem portion 26. In an embodiment, a length of the
longitudinal axis of the introducer section 20 ranges from about 3
mm to about 5 mm. In an embodiment, the mouth portion 24 has an
initial diameter ranging from about 7 mm to about 9 mm. In an
embodiment, the mouth portion 24 has a final diameter ranging from
about 0.6 mm to about 2 mm. In an embodiment, a diameter of the
stem portion 26 is from about 0.6 mm to about 2 mm. In an
embodiment, the length of the stem portion 26 is from about 3 mm to
about 4 mm.
[0027] The transfer section 30 has a proximal end 32, a distal end
34, and a longitudinal axis therebetween. The transfer section 30
is that portion of the assembly 10 that attaches directly, or
indirectly to the inlet port on the medical device, as well as that
portion of the assembly 10 in which the auxiliary instrument exits
the assembly 10 and enters the accessory channel of the medical
device. The transfer section 30 is capable of stretching to fit
around various different adaptor pieces, as well as around the
inlet port of the medical device. The transfer section 30
terminates at the distal end 14 of the assembly 10. In an
embodiment, the proximal end 32 of the transfer section 30 is
larger than the distal end 34 of the transfer section 30. In an
embodiment, a length of the longitudinal axis of the transfer
section of the transfer section 30 ranges from about 5 mm to about
9 mm.
[0028] The flexible membrane 28 is at a junction between the stem
portion 26 and the proximal end 32 of the transfer section 30. The
membrane 28 extends from and covers an entire opening created at
the junction, therefore a diameter of the membrane 28 is
substantially the same as the diameter of the stem portion 26. In
an embodiment, a thickness of the membrane 28 extends from the stem
portion 26 and into the transfer section 30. In an embodiment, the
membrane 28 is an extension of outer walls of the stem portion 26
to form the covering of the opening created at the junction. In an
embodiment, the membrane 28 is a separate piece of material that
has been added to or extends from the assembly at the junction
between the stem portion 26 and the proximal end 32 of the transfer
section 30. The membrane 28 is designed to have a desired
thickness, such that the membrane 28 is capable of stretching to a
maximum convexity when pressure is applied to the membrane 28 by
the auxiliary instrument and before being pierced by the auxiliary
instrument. Prior to the introduction of the auxiliary instrument
through the assembly 10, the membrane 28 is fully in-tact, meaning
that there are no holes or perforations in the membrane 28.
Therefore, when the assembly 10 is placed over the inlet port of
the medical device, such as a hysteroscope, there is no need for
extra valves or fittings to be placed on the hysteroscope for the
prevention of fluid leakage out of the port. The fully in-tact
membrane 28 provides this leakage protection. In an embodiment, the
membrane 28 has a diameter ranging from about 0.6 mm to about 2 mm.
In an embodiment, the membrane 28 has a thickness ranging from
about 0.3 mm to about 2 mm. A ratio of the thickness of the
self-sealing membrane 28 to the diameter of the self sealing
membrane 28 is chosen such that the self sealing membrane 28
remains substantially closed after being pierced by an auxiliary
instrument, even if fluid or gas pressure is present in the
assembly 10. Even after the auxiliary instrument is removed from
the membrane 28, the membrane 28 is capable of recovering to
substantially an original shape. This substantial original shape
will prevent leakage even though the membrane 28 has been pierced
and pressure still exists in the assembly 10.
[0029] FIG. 1C shows a cross-sectional view of the assembly 10. In
an embodiment, the length of the stem portion 26 is less than the
length of the mouth portion 24. In an embodiment, the length of the
stem portion 26 is about 9/10 the length of the mouth portion 24.
In an embodiment, the length of the stem portion 26 is about 3.5
mm. In an embodiment, the length of the mouth portion 24 is about
3.9 mm. In an embodiment, the diameter of the mouth portion 24
gradually decreases such that an initial diameter of the mouth
portion 24 is about 10 times as much as a final diameter of the
mouth portion 24 and a diameter of the stem portion 26. In an
embodiment, the diameter of the mouth portion 24 gradually
decreases such that an initial diameter of the mouth portion 24 is
about 5 times as much as a final diameter of the mouth portion 24
and a diameter of the stem portion 26. In an embodiment, the
initial diameter of the mouth portion 24 is in a range of about 6
mm to about 12 mm. In an embodiment, the final diameter of the
mouth portion 24 is in a range of about 0.6 mm to about 2 mm. In an
embodiment, the diameter of the stem portion 26 is in a range of
about 0.6 mm to about 2 mm. In an embodiment, the length of the
transfer section 30 is longer than the length of the introducer
section 20. In an embodiment, the length of the introducer section
20 is about 7.5 mm. In an embodiment, the length of the transfer
section 30 is about 8 mm. In an embodiment, the diameter of the
membrane 28 is in a range of about 0.6 mm to about 2 mm. In an
embodiment, the thickness of the membrane 28 is about 5 times less
than the length of the stem portion 26. In an embodiment, the
thickness of the membrane 28 is about 0.9 mm. In an embodiment, the
thickness of the membrane 28 is approximately no less than 1/3 of
the diameter of the membrane 28.
[0030] The assembly 10 is fabricated from a single piece of medical
grade elastomeric material. In an embodiment, the elastomeric
material is a silicone elastomer. Silicone elastomer has strong
memory or rebound characteristics, may be sterilized, and is
biocompatible. In a particular embodiment, the silicone elastomer
is translucent. The translucent characteristic of the silicone
elastomer may aid a user of the assembly 10 during a medical
procedure. For example, in certain situations the user may be
removing a piece of biopsy tissue or a polyp from the uterus of a
patient. After the tissue or the polyp is removed from the uterus,
the tissue will need to be retrieved from the patient by passing
the tissue or polyp back out through the assembly 10. The
translucent characteristic of the assembly 10 will allow the user
to easily find, locate and remove the tissue or polyp from the
assembly 10, thus minimizing a common complication of existing
seals, where the tissue or polyp becomes "lost" in the seal.
Additionally, the translucency of the assembly 10 allows the user
to clearly visualize the angle of the auxiliary instrument as the
instrument penetrates the assembly 10. This will decrease
undesirable positioning which may lead to damage of the auxiliary
instrument. In an embodiment, the translucent silicone elastomer is
Silastic.RTM. which is manufactured by Dow Corning Corporation and
is approximately 50 durometer Shore A. In an embodiment, the
assembly 10 is designed to be water tight under pressure no greater
than about 100 mmHg. In an embodiment, the membrane 28 of the
assembly 10 may be punctured with a blunt obturator prior to
use.
[0031] Typical prior art seals are not disposable, and must be
taken apart and cleaned between uses. This adds to the difficulty
of carrying out an endoscopic diagnosis and adds significantly to
the cost of examination. Also, a non-disposable seal that is not
sterilized properly may introduce bacteria and other harmful agents
to a patient, and therefore the risk of cross-contamination between
patients is high. The assembly 10 of the present disclosure is
provided for single-use, and therefore is made to be
disposable.
[0032] FIG. 2A shows a top view looking at the proximal end 12 of
the assembly 10. As seen in FIG. 2A, the diameter of the stem
portion 26 is much smaller than the initial diameter of the conical
mouth 24, allowing for a user to efficiently introduce the
auxiliary instrument into the assembly 10. The wide conical mouth
24 allows for the auxiliary instrument to "self-introduce" into the
assembly 10. The proximal lip 18a of the middle region 17 is also
visible from this view. FIG. 2B shows a bottom view looking at the
distal end 14 of the assembly 10. In this view, the transfer
section 30 is visible, as is the distal lip 18b of the middle
region 17. The transfer section 30 is able to accommodate various
types of fittings that may be present on the inlet port of the
medical device, such as, for example, a Luer-lock fitting or a
ball-and-socket fitting. A major deficiency in the seal plugs in
the art is the lack of adaptability of such devices to endoscopes
and hysteroscopes that typically include anything other than a flat
ended sheath at the accessory channel port. However, many
endoscopes and hysteroscopes typically instead include a
ball-and-socket fitting at the accessory channel port to provide
flexibility and maneuverability to the auxiliary instrument when it
is introduced into the endoscope or hysteroscope. It is at this
ball-and-socket fitting that fluid might escape if an improper seal
is provided. Because the transfer section 30 of the assembly 10 of
the presently disclosed embodiments is made from an elastomeric
material, it may be stretched to accommodate various types of
adaptors. The properties of the elastomeric material allow the
transfer section 30 to stretch to fit around the adaptor or around
the inlet port of the accessory channel.
[0033] During a medical procedure, a user will engage the assembly
10 either to a Luer-lock adaptor for connection to a Luer-lock
fitted accessory channel of a medical device, or alternatively
directly to a traditional accessory channel of the medical device,
such as a ball end adaptor fitted accessory channel. As shown in
FIGS. 3A, 3B and 3C, an assembly 10 is being engaged to a Luer-lock
adaptor 40 having a port 41 and a lock 43. The assembly 10 has an
elastic band 15 wrapped around the cavity 19. The elastic band 15
helps a user of the assembly 10 to visually determine the
measurement of the diameter of the stem portion 26. For example, in
an embodiment the elastic band 15 is orange, which represents a 0.6
mm diameter stem portion 26. In an embodiment, the elastic band 15
is teal, which represents a 1.2 mm diameter stem portion 26. The
transfer section 30 is able to accommodate the port 41 on the
Luer-lock adaptor 40. The port 41 is squeezed into the transfer
section 30 of assembly 10, such that the Luer-lock adaptor 40 has a
snug fit with the transfer section 30. A hole in the port 41
surrounds the membrane 28 of the assembly 10 such that an auxiliary
instrument that passes through the membrane 28 can easily pass into
the port 41 of the Luer-lock adaptor 40. As shown in FIGS. 4A and
4B, the assembly 10 engaged to the Luer-lock adaptor 40 is being
attached to a Luer-lock fitted accessory channel 52 on a
hysteroscope 50. Briefly, the lock 43 of the Luer-lock adaptor 40
is slid over the Luer-lock fitted accessory channel 52 and turned
clockwise until the Luer-lock adaptor 40 is locked into place. The
Luer-lock adaptor 40 can be pulled back slightly to confirm that
the Luer-lock adaptor 40 is locked into place on the Luer-lock
fitted accessory channel 52 of the hysteroscope 50. As shown in the
embodiment depicted in FIGS. 5A, 5B and 5C, the assembly 10 may be
attached directly to a ball end adaptor fitted accessory channel 62
on a hysteroscope 60. Briefly, the transfer section 30 of assembly
10 is placed directly onto the ball end adaptor fitted accessory
channel 62. The assembly 10 is pushed onto the ball end adaptor
fitted accessory channel 62 until a tight fit is confirmed, by
pulling on the assembly 10 to make sure that the assembly 10 has a
snug fit.
[0034] An auxiliary instrument may be introduced into the
introducer section 20 of the assembly 10 and moved from the wide
mouth portion 24 through the narrow stem portion 26 until it
reaches the membrane 28. As an instrument moves through the stem
portion 26, the instrument is being squeezed and guided by the
narrow stem portion 26, providing complete contact between the
instrument and the stem portion 26 throughout the entire length of
the stem portion 26. When the instrument reaches the membrane 28, a
slight resistance will be felt by the user. Pressure exerted by the
instrument on the membrane 28, results in the stretching of the
membrane 28 in a direction from the proximal end 32 of the transfer
section 30 towards the distal end 34 of the transfer section 30.
The stretched membrane 28 surrounds at least a portion of the
instrument and when sufficient pressure is exerted on the membrane
28 by the instrument, a hole is created in the membrane 28. The
instrument passes through the hole in the membrane 28, enters the
proximal end 32 of the transfer section 30, followed by passing
through the distal end 34. The instrument may then enter into the
accessory channel of the medical device. The membrane 28 and the
stem portion 26 squeeze and surround the auxiliary instrument
resulting in a fluid-seal around the auxiliary instrument. The
elastomeric assembly with the desired thickness membrane 28, and
desired length stem portion 26 help ensure a tight, snug and solid
fluid-seal around the auxiliary instrument. Even if the user
manipulates the auxiliary instrument during the procedure, the
membrane 28, which extends from the stem portion 26, will move with
the stem portion 26 and the fluid-seal will remain.
[0035] The stem portion 26 and the membrane 28 squeeze the
instrument and provide multiple points of contact with the
instrument such that any movement that the instrument makes, the
membrane 28 and the stem portion 26 will mimic along. This
"mimicking" of the membrane 28 and the stem portion 26 to the
movements of the instrument are necessary for maintaining the
fluid-seal. Without being limited to any particular theory, there
are a number of unique features of the assembly 10 that makes this
mimicking possible. The length of the stem portion 26 is chosen
such that the stem portion 26 guides the instrument towards a
center of the membrane 28. The membrane 28 extends from the stem
portion 26 such that any lateral movement imparted on the stem
portion 26 by the auxiliary instrument will be transferred to the
membrane 28 such that the center of the membrane 28 is always
aligned with a center of the auxiliary instrument. This "floating
membrane" design insures leakage is prevented during any lateral
movement by the auxiliary instrument. The diameter of the stem
portion 26 is chosen such that instrument remains in contact with
and is squeezed by the stem portion 26 along the entire length of
the stem portion 26. The flexible elastomeric material that the
stem portion 26 and the membrane 28 are fabricated from provide
maneuverability to the stem portion 26 and the membrane 28. This
maneuverability allows the stem portion 26 and the membrane 28 to
move along with the instrument during the procedure. The thickness
of the membrane 28 is chosen such that the membrane 28 will
puncture when pressure is applied to the membrane 28 by the
instrument. The membrane 28 stretches and surrounds the instrument
until a peak pressure is achieved which causes the instrument to
penetrate the membrane 28.
[0036] When the auxiliary instrument no longer is needed for the
medical procedure, the instrument can be taken out of the assembly
10 without the need to worry whether the assembly will maintain a
fluid or a gas seal. The stem portion 26 directs the instrument out
of the assembly 10 and prevents an angled penetration when the
instrument is removed. When the auxiliary instrument is pulled back
through the membrane 28 and the stem portion 26, the hole that was
created in the membrane 28 rebounds back such that the membrane 28
returns substantially to the original shape. The ratio of the
thickness of the membrane 28 to the diameter of the membrane 28 is
chosen such that the membrane 28 substantially returns to the
original shape even under fluid or gas pressure, maintaining a
fluid-seal even when the instrument is no longer within the
assembly 10.
[0037] The self-sealing assemblies 10 of the present disclosure may
be used, in an embodiment, during a hysteroscopy procedure. During
a hysteroscopy procedure, a hysteroscope, a thin telescope, is
inserted through the cervix into the uterus. In an embodiment, a
self-sealing assembly 10 is used during a diagnostic hysteroscopy
procedure. In an embodiment, a self-sealing assembly 10 is used
during an operative hysteroscopy procedure. The hysteroscope used
for operative hysteroscopy typically includes at least one channel
in which it is possible to insert auxiliary instruments for
operative purposes, such as a biopsy of uterine tissue or the
removal of a polyp. A self-sealing assembly 10 of the present
disclosure may be used during an operative hysteroscopy procedure.
The self-sealing assembly 10 is capable of minimizing the backflow
of non-viscous uterine distention fluid when there is either no
auxiliary instrument being used in the assembly 10, when there is
an auxiliary instrument within the assembly 10, and after the
auxiliary instrument has been withdrawn from the assembly 10.
[0038] A method for performing an operative hysteroscopy procedure
includes connecting an self-sealing assembly to an operative
channel of a hysteroscope, wherein the self-sealing assembly
comprises an introducer section, a transfer section, and a membrane
therebetween, wherein the introducer section is approximately
funnel-shaped, having a first portion, a second portion, and a
longitudinal axis therebetween, wherein the first portion has a
gradually decreasing diameter over a first length, and wherein the
second portion has a substantially constant diameter over a second
length, wherein the membrane is fabricated from a single piece
translucent elastomeric material having a thickness such that the
membrane is capable of stretching when pressure is applied to the
membrane by an auxiliary instrument, and wherein the transfer
section of the self-sealing assembly is attached to the operative
channel of the hysteroscope; numbing a cervix of a subject using an
anesthetic; inserting the hysteroscope into a uterus of the
subject; distending the uterus with either liquid or gaseous media;
inserting the auxiliary instrument into the first portion of the
self-sealing assembly; pushing the auxiliary instrument through the
first portion and into the second portion of the self-sealing
assembly until the auxiliary instrument reaches the membrane;
pressurizing the membrane with the auxiliary instrument such that
the membrane stretches in a direction from a proximal end of the
transfer section towards a distal end of the transfer section;
surrounding at least a portion of the auxiliary instrument with the
membrane as the auxiliary instrument puts pressure on the membrane;
creating a hole in the membrane such that the auxiliary instrument
passes through the membrane and into the transfer section, wherein
an inner surface of the hole created in the membrane engages the
auxiliary instrument resulting in a fluid-seal around the auxiliary
instrument; moving the auxiliary instrument through the operative
channel until the auxiliary instrument reaches the uterus, wherein
the auxiliary instrument remains surrounded by the membrane, and
wherein the membrane mimics the movement of the auxiliary
instrument as the user manipulates the auxiliary instrument within
the operative channel; performing the hysteroscopy procedure;
pulling the auxiliary instrument back through the self-sealing
assembly, wherein when the auxiliary instrument is pulled back
through the membrane and into the introducer section, the hole
created in the membrane relaxes so that the hole is substantially
closed resulting in a fluid-seal; and removing the hysteroscope
from the uterus. The method for performing the operative
hysteroscopy procedure prevents (substantially minimizes) the
backflow of non-viscous uterine distention fluid.
[0039] A method for establishing a fluid-seal around a medical
instrument includes providing a medical device having an accessory
channel; attaching an assembly to the accessory channel of the
medical device, wherein the assembly comprises an introducer
section, a transfer section, and a self-sealing membrane
therebetween, wherein the introducer section is approximately
funnel-shaped, having a first portion, a second portion, and a
longitudinal axis therebetween, wherein the first portion has a
gradually decreasing diameter over a first length, and wherein the
second portion has a substantially constant diameter over a second
length, wherein the self-sealing membrane is fabricated from a
single piece flexible elastomeric material having a thickness such
that the self-sealing membrane is capable of stretching when
pressure is applied to the self-sealing membrane, and wherein the
transfer section is attached to the accessory channel of the
medical device; introducing the medical instrument into the
introducer section of the assembly such that the medical instrument
moves through the first portion and into the second portion,
wherein the first portion guides the medical instrument into the
second portion, and wherein the second portion contacts and
squeezes the medical instrument as the medical instrument passes
through the length of the second portion; exerting pressure on the
self-sealing membrane by the medical instrument resulting in the
self-sealing membrane stretching in a direction from a proximal end
of the transfer section towards a distal end of the transfer
section; surrounding at least a portion of the medical instrument
with the self-sealing membrane as the medical instrument puts
pressure on the self-sealing membrane; and creating a hole in the
self-sealing membrane such that the medical instrument passes
through the self-sealing membrane and into the transfer section,
wherein an inner surface of the hole created in the self-sealing
membrane engages the medical instrument resulting in the fluid-seal
around the medical instrument.
[0040] All patents, patent applications, and published references
cited herein are hereby incorporated by reference in their
entirety. It will be appreciated that several of the
above-disclosed and other features and functions, or alternatives
thereof, may be desirably combined into many other different
systems or applications. Various presently unforeseen or
unanticipated alternatives, modifications, variations, or
improvements therein may be subsequently made by those skilled in
the art which are also intended to be encompassed by the following
claims.
* * * * *